System and method for vessel access closure

ABSTRACT

Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/974,489, filed Dec. 21, 2010, which claims the benefit under 35U.S.C. §119 to U.S. Provisional Application Ser. Nos. 61/308,589, filedFeb. 26, 2010 and 61/353,561, filed Jun. 10, 2010. The foregoingapplications are hereby incorporated by reference into the presentapplication in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to closure of surgically createdvascular access ports or holes, such as arteriotomies, and morespecifically to closure technologies pertinent to relatively largesurgically-created access defects.

BACKGROUND

Minimally invasive diagnostic and interventional procedure prevalence inUS and foreign hospitals continues to increase, as does the demand forcertain procedures which involve placement of relatively large devicesinto targeted locations that are initially accessed through thevasculature. For example, percutaneous prosthetic heart valve placementand abdominal aortic aneurysm stent graft procedures that are notaccomplished using one or more trans-thoracic or trans-abdominal accessports generally involve one or more femoral arteriotomies which may belarge in size relative to conventional femoral arteriotomies, due, atleast in part, to the size of devices utilized for such procedures.Subsequent to completion of the diagnostic or interventional aspects ofsuch treatments, any associated arteriotomies generally must be closed.While there are existing technologies for closing defects created inveins and arteries due to diagnostic and/or interventional tool access,such as those available from St. Jude Medical, Inc., AbbottLaboratories, Inc., and Access Closure, Inc. under the tradenamesAngio-Seal®, StarClose®, and Mynx®, respectively, none of these are wellsuited for closing relatively large defects—particularly not in thearterial environment wherein relatively high flow rate and pressure arecomplicating factors.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1E illustrate aspects of an access closure device deploymentwherein a collapsed device is passed through an introducer lumen to atargeted intravascular deployment position before it is deployed.

FIGS. 1F and 1G illustrate cross sectional views of two differentembodiments of deployed closure device configurations.

FIGS. 1H-1J illustrate orthogonal views of two different embodiments ofdeployed closure device configurations.

FIGS. 1K and 1L illustrate cross sectional views of two differentembodiments of deployed closure device configurations.

FIGS. 2A-2F illustrate aspects of an access closure device deploymentwherein a two-portion collapsed device is passed through an introducerlumen to a targeted intravascular deployment position before expansion.

FIGS. 2G-2I illustrate side views and an orthogonal view, respectively,of a suitable device frame configuration.

FIGS. 3A-3D illustrate orthogonal views of a device embodiment that maybe rolled up into a collapsed shape, and unrolled or unfurled to anexpanded shape.

FIG. 4 illustrates one embodiment of a manual operational interfaceconfiguration.

FIG. 5 illustrates various aspects of an arteriotomy closure method inaccordance with the present invention.

FIGS. 6A to 6Z-1 illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIGS. 7A-7F illustrate various aspects of an arteriotomy closure devicedeployment wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIG. 8A illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 6A-6X, wherein a foot is pre-biased toflex once released from a restraining sheath.

FIG. 8B illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 6A-6X, wherein a foot is flexed afterrelease from a restraining sheath, subsequent to application of aflexing load.

FIGS. 9A-9E illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIG. 10 illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 9A-9E, wherein a foot is pre-biased toflex once released from a restraining sheath.

FIG. 11 illustrates aspects of a deployment sheath configured to assistan operator with positioning of related instrumentation adjacent anarteriotomy location.

FIGS. 12A-12D illustrate aspects of a proximal deployment interfacewhich may be utilized with closure device deployment configurations suchas those depicted in FIGS. 9A-9E.

FIGS. 13A-13D illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be deployed asfacilitated by a catch member configured to prevent withdrawal of theclosure device after insertion through the arteriotomy.

FIGS. 14A-14B illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be deployed asfacilitated by a catch member configured to prevent withdrawal of theclosure device after insertion through the arteriotomy.

FIGS. 15A-15C illustrate three views of a closure device frameconfiguration comprising a catch member configured to prevent withdrawalafter insertion through an arteriotomy and subsequent expansion in situ.

FIGS. 16A-16K illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be deployed asfacilitated by a catch member configured to prevent withdrawal of theclosure device after insertion through the arteriotomy.

FIG. 17 illustrates various aspects of a process flow for deploying anarteriotomy closure configuration wherein a collapsed closure device maybe deployed as facilitated by a catch member configured to preventwithdrawal of the closure device after insertion through thearteriotomy.

FIGS. 18A-18C illustrate various aspects of a closure deviceconfiguration wherein each structure thereof may comprise abioresorbable material, and wherein expansion from a collapsed state toan expanded state may comprise an unfurling transformation.

FIG. 19 illustrates various aspects of a process flow for deploying anarteriotomy closure configuration wherein a collapsed closure device maybe deployed and expanded in an unfurling transformation.

FIGS. 20A-20K illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be deployed asfacilitated by a catch member configured to prevent withdrawal of theclosure device after insertion through the arteriotomy, and wherein aguidewire may be left in place to facilitate easy re-access to theendovascular structures near the arteriotomy.

FIG. 21 illustrates various aspects of a process flow for deploying anarteriotomy closure configuration wherein a guidewire may be left inplace to facilitate easy re-access to the endovascular structures nearthe arteriotomy.

FIGS. 22A-22C illustrate various aspects of embodiments configured toemploy an elongate guiding member such as a guidewire to facilitate easeof re-access after closure.

FIGS. 23A-23C illustrate various aspects of embodiments configured toemploy a proximal catch member to effect a hole closure, and in theembodiments of FIGS. 23B and 23C, a distal catch member as well.

FIG. 24 illustrates various aspects of a process flow for deploying anarteriotomy closure configuration wherein a guidewire may be left inplace to facilitate easy re-access to the endovascular structures nearthe arteriotomy.

FIG. 25 illustrates various aspects of a process flow for deploying anarteriotomy closure configuration wherein a guidewire may be left inplace to facilitate easy re-access to the endovascular structures nearthe arteriotomy.

SUMMARY

One embodiment is directed to a method for closing a hole in a vessel,comprising: inserting through the hole an implantable closure devicehaving proximal and distal ends and being expandable from a collapsedstate to an expanded state, the expanded state providing a geometrysufficient to substantially occlude the hole; inserting a distal portionof an elongate guiding member through the hole and into a vascular lumenformed by the vessel; and controllably expanding the implantable closuredevice to the expanded state to occlude the hole, while leaving thedistal portion of the elongate guiding member extending into thevascular lumen. The method may further comprise inserting an introducersheath through the hole, the introducer sheath defining an introducerlumen sized to accommodate insertion of the collapsed state of theclosure device. Inserting may comprise advancing the implantable closuredevice relative to the hole with a deployment member having a proximalportion configured for manual manipulation and a distal portionconfigured to be removably coupled to the implantable closure device.The method may further comprise controllably moving the collapsedclosure device relative to the deployment member to place the closuredevice into a geometric configuration relative to the vascular lumenthat is selected to prevent withdrawal of the closure device back out ofthe hole. Controllably moving may comprise rotating the collapsedclosure device relative to the deployment member to place the closuredevice into a rotated orientation selected to prevent withdrawal of theclosure device back out of the hole when the deployment member iswithdrawn. Controllably moving may comprise translating the collapsedclosure device relative to the deployment member to place the closuredevice into compression against a portion of the deployment member.Translating may cause the collapsed closure device to controllablyrotate to a rotated orientation selected to prevent withdrawal of theclosure device back out of the hole. The method may further compriseadvancing an assembly of a delivery sheath and collapsed implantableclosure device, at least a portion of which is removably positionedwithin the introducer lumen, to a deployment position within thevascular lumen wherein reconfiguration of the implantable device fromthe collapsed state to the expanded state is desired, and maintainingthe position of the collapsed implantable device while retracting thedelivery sheath to expose the collapsed implantable device to thevascular lumen. The method may further comprise selecting the deploymentposition based at least in part upon an indication from a bleedbackindicator channel. The method may further comprise urging the expandedimplantable closure device toward the hole, wherein the expanded stateis configured to contact at least 90 degrees of an inner surface of thevessel adjacent the hole relative to a longitudinal axis of the vascularlumen, and to restrict fluids from exiting the vascular lumen throughthe hole. The closure device may be a self expanding structureconfigured to expand itself from the collapsed state to the expandedstate when not restrained in the collapsed state. Controllably expandingmay comprise moving a portion of a deployment tensile element relativeto the self expanding structure to allow the self expanding structure toexpand itself to the expanded state. The closure device expanded statemay form a substantially cylindrical shape defining a lumentherethrough. The elongate guiding member may comprise a guidewire.Inserting the elongate guiding member through the hole may compriseadvancing the elongate guiding member through a lumen defined throughthe deployment member. The elongate guiding member may be removablycoupled to the implantable closure device. The method may furthercomprise decoupling the deployment member from the implantable closuredevice while leaving the distal portion of the elongate guiding memberextending into the vascular lumen. The method may further compriseengaging the elongate guiding member to re-enter the vascular lumen inan over-the-wire configuration. The method may further comprise removingthe elongate guiding member from the vascular lumen. At least the distalportion of the elongate guiding member may comprise a radioopaquematerial selected to be visible with fluoroscopic imaging. Theimplantable closure device may be inserted through the hole before theelongate guiding member or after the elongate guiding member. Theimplantable closure device may be inserted through the hole and over theelongate guiding member in an over-the-wire configuration.

DETAILED DESCRIPTION

Referring again to FIG. 1A, an introducer catheter (2) is shown with itsdistal tip (6) inserted across a hole formed in a blood vessel, such asan arteriotomy (28), which has been created in a blood vessel such asthe femoral artery (22) to provide transvascular access for a proceduresuch as a percutaneous heart valve installation. The hole or arteriotomy(28) may have a diameter as large as 18 French or larger. In FIG. 1A,the valve deployment related tooling has been removed, and hemostasisthrough the lumen (4) defined through the introducer (2) may becontrolled, for example, with valves integrated into the introducer orpositive flush from an associated flush assembly (8). The embodimentdepicted in FIG. 1A shows a closure device assembly being insertedthrough the introducer to facilitate execution of a controlledarteriotomy closure, the device assembly generally comprising acollapsed closure device (14), an elongate deployment member (10) havinga distal portion (12) configured to removably accommodate the collapseddevice (14), an insertion/retraction member (16) removably coupled withthe device (14), a deployment tension member (18) configured to causethe collapsed device (14) be expandable to a deployed or expanded shape,and an attachment tension member (20) configured to pull the deviceproximally toward the operator of the assembly. In one embodiment theclosure device (14) may be selected to span and close an arteriotomyhaving a diameter as large as 18 French or larger. The elongatedeployment member preferably comprises a flexible material construct,such as a polymer extrusion. The deployment and attachment tensionmembers preferably comprise relatively small diameter sutures, wires, ortensile load bearing lines made from polymers and/or metals, such aspolyethylene, polyethylene terepthalate, stainless steel, titanium,nitinol, and the like. An insertion/retraction member (16) preferably iscapable of not only withstanding tensile loads, but also relativelylow-level compressive loads, as in a scenario wherein such structure isutilized to push a device (14) distally. Suitable materials for aninsertion/retraction member (16) include the polymers and metalsmentioned above in reference to the tension members (18, 20; inconstruction, given the desirable compressive functionality in additionto tensile, the insertion/retraction member generally will be stiffer,and potentially larger in diameter, as compared with such tensionmembers (18, 20). The collapsed closure device (14) may comprise aplurality of flexible structural frame elements coupled together to forma collapsible and expandable member having an outer shape that issubstantially cylindrical in both collapsed form and expanded form, anddefining a lumen through the cylindrical expanded form, with generallyno lumen defined through the generally cylindrical collapsed form.Further description of suitable closure device (14) details is featuredbelow.

Referring to FIG. 1B, the delivery member (10) has been inserted fartherthrough the introducer (2), and the distal portion (12) of the deliverymember (10), with the collapsed device (14) confined therein, is beingpositioned past the distal tip of the introducer (6) and into the bloodvessel (22).

Referring to FIG. 1C, with insertion of the insertion/retraction member(16) relative to the delivery member (10), the collapsed device (14) maybe pushed out of the confining distal portion (12) of the deliverymember (10) and into the free bloodstream space of the vessel (22). Theattachment tension member (20) may then be tensioned to maintain thecollapsed device in a position adjacent to the distal tip (6) of theintroducer (2) as the delivery member (10) is retracted relative to theintroducer (2), as shown in FIG. 1C.

Referring to FIG. 1D, with tensioning of the deployment tension member(element 18 in FIGS. 1A-1C), the device may be allowed to expand to anexpanded shape (element 24 refers to the expanded form of the previouslycollapsed closure device, element 14) preferably substantially occupyingthe entire cross section of the blood vessel (22) and spanning wellbeyond the diameter of the arteriotomy (28) with space on either side toprevent exit of the closure device (24) through the arteriotomy (28).The deployment tension member (18) may comprise an elongate cable,suture, string, or the like configured to occupy very little crosssectional space, and to be able to withstand tensile loading sufficient,for example, to untie a knot configured to maintain the device in acollapsed configuration. One suitable tying or knot configurationcomprises what is known as a “highwayman's hitch” tied around thecollapsed device (element 14 in FIGS. 1A-1C); with such a configuration,a controlled tensile pull on the deployment tension member from anoperator at the proximal end of the instrument assembly causes thehighwayman's hitch to untie, allowing the device to expand. Expansionfrom a collapsed state to an expanded state may be accomplished using aself-expanding device structure configured to expand itself to a finalexpanded shape, or an expandable shape configured to be expanded from acollapsed state to an expanded shape with the assistance of a balloon orother expansion device which may be placed through the device. Inanother embodiment, an expansion device comprising an expandable balloonor other expandable member configured to controllably expand based atleast in part upon thermal energy, electric energy, shape memory, and/orhydrophilic expansion may be utilized to complete expansion of a deviceconfiguration which at least partially expands on its own, but which mayrequire assistance to expand fully. As shown in FIG. 1D, the expandedclosure device (24) remains coupled to the attachment tension member(20), and the introducer remains located adjacent to the expanded device(24), holding the arteriotomy (28) open and providing a conduit for theattachment tension member to be used to make small adjustments in thepositioning of the expanded device (24) relative to the blood vessel(22) structure.

Referring to FIG. 1E, with the expanded device (24) in a desirableposition, the introducer catheter (2) has been removed, allowing thearteriotomy (28) to close to a greater degree as it still surrounds theattachment tension member (20) which continues to be coupled to theexpanded device (24). The attachment tension member (20) may then bereleased or uncoupled from the deployed device (24) with a cutting tool(26), or controlled detachment configuration, such as a small mechanicallatch or fitting, or a controlled release link configuration described,for example, in U.S. Pat. No. 5,122,136, which is incorporated byreference herein in its entirety. Uncoupling of the attachment tensionmember (20) from the device (24) allows for the arteriotomy (28) tobecome substantially or completely closed, leaving behind an accessclosure supported at least in part by the expanded device.

FIG. 1F depicts a cross sectional view of the configuration illustratedin FIG. 1E. Referring to FIG. 1F, the attachment tension member (20) isshown coupled to the expanded closure device (24) and leading out of thecollapsing/closing arteriotomy (28). Subsequent to decoupling of theattachment tension member (20) from the device (24), complete hemostasisof the arteriotomy may be accomplished based upon one or more of severalfactors: 1) the device may be configured to bias the arteriotomy closed;2) the vessel wall tissue defining the arteriotomy therethroughgenerally is self-biased to close (with a somewhat spring-like state oftissue mechanics in a vessel wall, the wall is generally biased to closewhen mechanically allowed to do so); 3) the device (24) may comprise astructure or materials which are specifically configured to prevent theflow of blood through the wall at the location of the arteriotomy. Manysuitable construction variations may be utilized for the closure device(14, 24); for example, the device embodiment depicted in FIG. 1F,comprises a frame comprised of frame elements or structural members (30)which are coupled to a thin, sheetlike connecting material (34)configured to be substantially impermeable to blood, and therefore ablocking element is pressed adjacent the arteriotomy (28) location tofacilitate hemostasis across the arteriotomy (28) until it has healedshut. The outer surface of the structural member (30)/connectingmaterial (34) assembly may be coupled to cover structure (32), and maybe relatively thick (in one embodiment having a substantially uniformthickness of about 0.015 inches) as compared with the connectingmaterial (34), which may be further selected for its ability tofacilitate hemostasis of the arteriotomy (28). In one embodiment asuitable frame may be substantially cylindrical, with a diameter ofbetween 6 and 14 mm, more preferably between about 11 and 14 mm, and alength of between about 12 and 20 mm, more preferably about 16 mm; withsuch a configuration, an associated substantially rectangular covermember may have a length of between about 16 and 41 mm, more preferablybetween about 19 and 24 mm, and a perpendicular rectangular dimension ofbetween about 11 and 19 mm, more preferably about 15 mm. Suitablematerials for connecting material (34) and cover structures (32) includepolytetrafluoroethylene (“PTFE”), expanded polytetrafluoroethylene(“ePTFE”), polyethylene terepthalate (“PET”), polyesther, polylacticacid (“PLA”), poly glycolic acid (“PGA”), poly-lactic-co-glycolic acid,fluorinated ethylene-propylene, silicone, polyethylene, polyurethane,copolymers of any of the above, other polymers, as well as porcine orequine submucosa. The structural members (30) may comprise metals, suchas nitinol, or polymers, such as resorbable polymers, as described belowin reference to the construction of the collapsed (14) or expanded (24)forms of suitable closure devices.

In one embodiment, a cover structure may be biased to maintain asubstantially cylindrical outer surface shape, and to assist inspreading loads from the structural members (30) substantially uniformlyto surrounding tissue via such substantially cylindrical outer surfaceshape. The closure device embodiment depicted in FIG. 1F, when in theexpanded configuration as shown, forms a substantially cylindrical outershape defining a lumen therethrough; the substantially cylindrical outershape interfaces with substantially all (i.e., approximately 360 degreesof the circumferential inner surface 238 of the vessel 22 which definesthe vessel lumen 236) of the interior surface (238) of the blood vessel(22) in the region of the arteriotomy (28), including in thisembodiment, the portions of this inner surface (238) which extend alongthe longitudinal axis of the vessel on either side of the arteriotomy(28) for a given distance each way. In other words, if an arteriotomy iscreated at a position approximately midway along a two-inch-long,generally cylindrical vessel portion of interest, in one embodiment, aportion of the expanded closure device may be configured to interfacewith substantially all of the two-inch-long, generally cylindrical,inner surface (238). In other embodiments, an expanded closure devicemay be configured to interface with less than substantially all 360degrees of this circumferential surface. For example, Referring to FIG.1K, an embodiment is depicted that is similar to that depicted in FIG.1F, with the exception that an expanded closure device (240) directlyinterfaces with approximately 90 degrees (244) of the circumferentialinner surface (238) of the vessel (22). FIG. 1L depicts an embodimentwherein an expanded closure device (242) directly interfaces withapproximately 135 degrees (246) of the circumferential inner surface(238) of the vessel (22). The embodiment depicted in FIG. 1G varies fromthat of FIG. 1F in that the cover structure (32) of FIG. 1F isconfigured to cover substantially the entire approximately cylindricalouter surface of the structural member (30)/connecting material (34)assembly, while the cover structure (32) of FIG. 1G is configured tocover the approximately ⅔ of the approximately cylindrical outer surfaceof the structural member (30)/connecting material (34) assembly closestto the arteriotomy location.

Many closure device (14) variations are suitable, with general preferredcharacteristics being that the device be deployable through thearteriotomy in a collapsed state, and expandable once in the targetedvessel to an expanded state which promotes closure of the hole orarteriotomy through which it was delivered. For example, in oneembodiment shown in orthogonal view in FIG. 1H, the closure device maycomprise a simple scaffold or frame constructed of bent and straightportions of elongate structural members (30) in a coiled, meshed,zig-zag, or other pattern coupled to a cover structure (32) positionedto promote hemostasis of the arteriotomy (28). Such structural members(30) may, for example, comprise highly flexible metallic alloys orpolymeric materials, such as bioresorbable polymers. Suitable metallicalloys include nickel titanium alloys, such as the superalloy known asnitinol; other suitable materials include stainless steel, cobaltchrome, titanium, nickel, gold, tantalum, and alloys thereof. Suitablepolymeric materials include those comprising poly lactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), silicone, polyethylene,polyurethane, polyesther, and copolymers thereof.

In another embodiment, such as that shown in FIGS. 1I and 1J, a suitableclosure device (14) may comprise merely a scaffold or frame comprisingbent and/or straight portions of elongate structural member (30)material in a configuration that tends to bias an arteriotomy (28)closed when in a deployed/expanded configuration by urging adjacentvessel (22) wall tissue portions (36, 38) toward each other by means ofsmall hooks, or high-friction or protein binding materials that areconfigured to attach or adhere to the inside of the vessel wall.

In another embodiment, a closure device (14) may comprise an expandablescaffold or frame such as an intraluminal stent or stentlike structure.The stent may be self-expanding or balloon-expandable and may be a stentconfigured for any blood vessel including coronary arteries andperipheral arteries (e.g., renal, Superficial Femoral, Carotid, and thelike), a urethral stent, a biliary stent, a tracheal stent, agastrointestinal stent, or an esophageal stent, for example. Morespecifically, the stent may be, for example, a stent availablecommercially as a Wallstent, Palmaz-Shatz, Wiktor, Strecker, Cordis, AVEMicro Stent, Igaki-Tamai, Millenium Stent (Sahajanand MedicalTechnologies), Steeplechaser stent (Johnson & Johnson), Cypher (Johnson& Johnson), Sonic (Johnson & Johnson), BX Velocity (Johnson & Johnson),Flexmaster (JOMED) JoStent (JOMED), S7 Driver (Medtronic), R-Stent(Orbus), Tecnic stent (Sorin Biomedica), BiodivYsio (BiocompatiblesCardiovascular), Trimaxx (Abbott), DuraFlex (Avantec Vascular), NIRstent (Boston Scientific), Express 2 stent (Boston Scientific), Libertestent (Boston Scientific), Achieve (Cook/Guidant), S-Stent (Guidant),Vision (Guidant), Multi-Link Tetra (Guidant), Multi-Link Penta(Guidant), Multi-Link Vision (Guidant), Gianturco-Roubin FLEX-STENT®,GRII™, SUPRA-G, or V FLEX coronary stents from Cook Inc. (Bloomington,Ind.). Some exemplary stents are also disclosed in U.S. Pat. Nos.5,292,331 to Boneau, 6,090,127 to Globerman, 5,133,732 to Wiktor,4,739,762 to Palmaz, and 5,421,955 to Lau, each of which is incorporatedby reference herein in its entirety. Suitable expandable stentlikestructures are also disclosed in percutaneous valve configurationdisclosures. For example, the configuration disclosed in U.S. Pat. No.7,445,631 to Sadra Medical, Inc., absent the valve leaflets, may besuitably used in the subject application; U.S. publication 2009/0210052to Forster et al discloses (for example, FIGS. 2A-2C) a tri-starcollapsible frame configuration which may be utilized absent the valveleaflets in the subject application; each of these references isincorporated by reference herein in its entirety.

Any of the above devices, scaffolds, frames, stents, or stentlikestructures may be combined with strips, sheets, or sheetlike portions ofconnecting material, such as PTFE or ePTFE, to form what may be referredto as a variant of a stent graft. A suitable stent graft is described,for example, in PCT Publication WO 1997-021403 to Prograft Medical, andis incorporated by reference herein in its entirety. Further, any of theaforementioned frames may be coupled to a cover structure (with orwithout connecting material as well) comprising a metal or polymermaterial positioned to assist in maintaining hemostasis of thearteriotomy, as depicted in FIGS. 1F-1H.

Referring to FIG. 2A-2I, another embodiment is depicted wherein aclosure device (40) has two end portions coupled by a highly bendablemidportion. Referring to FIG. 2A, a distal tip (6) of an introducercatheter (2) is positioned through an arteriotomy (28) formed in a bloodvessel (22). In one embodiment, the arteriotomy may be as large as 18French or larger in diameter. An access closure device deploymentassembly is shown being advanced toward the introducer (2) in FIG. 2B,the assembly comprising an expandable device (40) removably coupled to adeployment tension member (19) and an attachment tension member (21),each of which are movably coupled through a device insertion/retractionmember (16) to a proximal location where they may be manipulated orcontrolled by an operator.

Referring to FIG. 2C, the insertion/retraction member (16) is withdrawnrelative to a delivery member (10), causing the collapsed device (40) tobecome disposed within the distal portion (12) of the delivery member(10). Such a configuration may be inserted into the introducer catheter(2), as shown in FIG. 2D, to dispose the collapsed device (40) past thedistal tip (6) of the introducer (2). Referring to FIG. 2E, theintroducer (2) may be withdrawn to urge the collapsed device (40) into aposition wherein it is approximately centered adjacent the arteriotomy(28) to provide a temporarily hemostasis through the arteriotomy (28).Referring to FIG. 2F, having placed the non-expanded device (40) in adesirable position as in FIG. 2E, the deployment tension member (19) maybe proximally tensioned to allow the device to expand, such as by usinga highwayman's hitch as described above, and the attachment tensionmember (21) may be subsequently uncoupled from the expanded device (42)to allow for the arteriotomy (28) to close and for the deliveryinstrumentation to be removed. As shown in FIG. 2F, for example, thedeployed device (42) spans across the longitudinal length of thearteriotomy (28) with extra length on both sides to provide stabilityand leak prevention. Referring to FIGS. 2G-2I, three views of a suitablestructural member frame for the deployment paradigm illustrated in FIGS.2A-2F are depicted to show that two substantially cylindrical endportions (44, 46) are coupled by a highly flexible mid portion (48) inthis embodiment, the midportion (48) preferably being positioneddirectly adjacent the arteriotomy location to provide support for theclosure (i.e., by urging a related cover member directly against thearteriotomy location); such preferred position/orientation of theflexible mid portion (48) may be accomplished, at least in part, byinterfacing a tensile member (not shown) directly with the midportion(48), for example by tying with a knot to one of the small aperturesshown in the midportion (48) embodiments of FIGS. 2G-2I. Tension on sucha tensile member is likely to assist with the orientation/positionselection described herein, either before or after allowing the deviceto reach its expanded state. Such structural members may comprisematerials similar to the structural members (30) described in referenceto FIGS. 1A-1J, and may be coupled to sheetlike members and/or covermembers for form a substantially cylindrical expanded device surfaceshape (as in the embodiment shown in FIG. 2F wherein a cover member 30extends around each of, and between (i.e., across the midportion 48span), the two zig zag cylindrical frame sub-portions 44, 46, to spanthe arteriotomy 28 and play a key role in effecting the closurethereof), which also may be similar to those (34, 32) described above inreference to FIGS. 1A-1J. In other words, the embodiment shown in FIGS.2A-2F, while delivered in a two-lobed collapsed form, may be expanded toform a substantially cylindrical shape due to a sheetlike member coupledacross the frame, and/or a cover member extended across the outersurfaces of the frame.

Referring to FIGS. 3A-3D, a roll-up type expandable device (5)configuration is depicted to illustrate that suitable prostheses neednot be conventionally radially expandable—they may be expanded byallowing, or mechanically facilitating (i.e., with an assisting devicesuch as a balloon or unrolling torque tool), the unrolling or unfurlingof a device that has been rolled into a smaller radial configuration, asillustrated in FIG. 3C.

Referring to FIG. 4, one embodiment of a handle is depicted fordeploying and actuating configurations such as those described inreference to FIGS. 1A-1J and 2A-I. As shown in FIG. 4, an actuatorhandle body (56) is movably coupled to a delivery member (16)insertion/retraction actuator slide button (54) and a deployment tensionmember (18, 19) tension actuation pull feature (52). Such aconfiguration allows for an operator to hold the handle body (56) in onehand and easily control insertion and retraction of theinsertion/retraction member (16) with a thumb or finger of the samehand, while also allowing for the operator to use fingers of the otherhand to pull the deployment tension member (18, 19) tension actuationpull feature (52) and allow a related device to expand or be expanded.

Referring to FIG. 5, a method is illustrated wherein an arteriotomy iscreated, an introducer inserted, and a diagnostic or interventional toolinserted through the introducer (58) to conduct a cardiovascularprocedure (60) such as a percutaneous valve replacement. After thediagnostic and/or interventional tool or tools have been retracted backthrough the introducer (62), it may be desirable to close thearteriotomy. A distal tip or portion of the introducer may be retractedto a position close to the arteriotomy (64) but still within the vessel,and a closure assembly comprising an expandable device configured tofacilitate hemostatic of the arteriotomy may be inserted through theintroducer toward the arteriotomy (66). The closure assembly distalportion may be inserted past the arteriotomy and into the vascular lumen(68), after which the device may be positioned and/or repositioned to adesired location relative to the arteriotomy and surrounding anatomy(70). The device may then be allowed to expand, or may be expanded, tocause hemostasis at the arteriotomy (72), and the closure assembly andintroducer may be withdrawn away from and detached from the expandeddevice, leaving a closed arteriotomy (74).

Referring to FIGS. 6A-6X, various aspects of another embodiment of aclosure assembly are depicted, wherein a collapsed closure device may becontrollably repositioned and/or reoriented during a deployment processin a manner that geometrically prevents such device from escaping thearteriotomy as other delivery tools subsequently are removed, and alsolimits or reduces blood or other fluids from escaping the arteriotomyonce the device has been expanded into a final configuration, therebyeffectively closing the arteriotomy. Referring to FIG. 6A, a deliveryassembly is depicted comprising an outer introducer sheath (2), adelivery sheath (76) placed through the working lumen of the introducersheath (2), and a arteriotomy closure device deployment assemblythreaded through the working lumen of the delivery sheath (76), theassembly being depicted in FIG. 6B without the sheaths and featuring acollapsed closure device (86) coupled to both an elongate deploymentmember (90) and a foot member (92), the foot member being threadedthrough a working lumen defined by a portion of the deployment member(90). In one embodiment, the delivery sheath (76) is configured toextend beyond the end of the introducer sheath (2) by between about 200and about 870 mm, and more preferably about 370 mm, and may have anouter diameter between about 10Fr and about 24Fr, and more particularlyabout 18Fr. The closure device (86) may comprise an expandable frame,scaffold, or prosthesis with or without associated sheetlike membersand/or cover members, and may be similar to those described above inreference to FIGS. 1A-3D, or below in reference to FIGS. 6K-6V. Adeployment tension member (82), such as a suture or wire, is threadedthrough another working lumen defined by a portion of the deploymentmember (90) and looped around the collapsed closure device (86) as wellas a portion of the foot member (92) to maintain the collapsedconfiguration of the closure device until the deployment tension memberis tensioned, causing a releasable knot (83), such as a highwayman'shitch, to release and allow the collapsed closure device to expand or beexpanded. An attachment tension member (84), such as a suture or wirethat may be resorbable, akin to the attachment tension members (20, 21)described above, is threaded through a lumen or channel defined by thefoot member (92) and tied to the closure device (84).

Referring to FIGS. 6C-6E, one configuration for controllablyrepositioning and/or reorienting a collapsed closure device (86) duringdeployment is configured. As shown in FIG. 6C, application of a load(100) to the elongate deployment member (90) initially will result in acompressive load at the interface (94) between the elongate deploymentmember (90) and the collapsed closure device (86). This compressiveloading may result in translational repositioning of the closure device(86) initially until there is no more slack in the attachment tensionmember (84), after which a moment will be effectively applied to theclosure device (86), causing it to rotate (98), or rotationallyreorient, relative to the elongate deployment member, as depicted inFIGS. 6D and 6E. FIG. 6E, in particular, diagrammatically illustratesthat a compressive interfacial load (94) applied along with a tensileload (96) through the attachment tension member (84) attached at adifferent location from the interfacial load application results in arotation actuation. In one embodiment, rotational actuation may beaccomplished by both actively tensioning the attachment tension member(84) and actively pushing the elongate delivery member (90). In otherembodiments, only one of such members (84, 90) may be actively loaded,with the other kept relatively stationary. For example, referring toFIG. 6D, the attachment tension member (84) is shown grounded oranchored at a proximal location, so that rotation of the collapsedclosure device (86) may be induced merely with compression or pushingupon the elongate deployment member (90) after slack in the attachmenttension member (84) has been eliminated. Such rotation causes bending orhinging of a distal portion of the foot member at a predetermined hingeor bending axis (102), and the amount of rotational reorientation may bephysically limited by the positions of distal portions of the elongatedelivery member (90).

Referring to FIGS. 6F-6H, components of the above described deliveryassembly are shown disassembled to some degree. FIG. 6F depicts a footmember (92) coupled to a collapsed closure device (86) with a deploymenttension member (82) and attachment tension member (84). FIG. 6Gillustrates an elongate deployment member comprising a first guide tube(104) coupled to a second guide tube (106) with a deployment memberouter layer (108), as shown in the orthogonal view of FIG. 6H. Bothguide tubes (104, 106) define working lumens therethrough (150, 152,respectively). In the assembly of FIG. 6C, for example, a deploymenttension member (82) may be passed through the first guide tube lumen(150), and a foot member (92), which itself defines a lumen throughwhich an attachment tension member (84) may be passed, may be placedthrough the second guide tube lumen (152).

Referring to FIGS. 6I and 6J, orthogonal side views of a foot member(92) embodiment are depicted. In the depicted embodiment, the proximalportion (142) of the foot member may comprise a flexible tube comprisinga polymer such as fluorinated ethylene-propylene, and the distal portion(110) may comprise a mechanically flattened continuation of such tubingconfigured with holes (112) to accommodate knots and fastening of adeployment tension member (element 82 in FIG. 6C, for example) and/orattachment tension member (element 84 in FIG. 6C, for example). A creaseis provided to create a preferred bending or hinging axis (102) betweenthe proximal (142) and distal (110) portions of the foot member. Inanother embodiment, the proximal portion (142) of the foot member maycomprise a reinforcing material or member, such as a piece of metalhypotube, to increase the structural modulus of such portion andfacilitate precise positioning and loading of such portion to maneuverthe delivery assembly or portions thereof.

Referring to FIGS. 6K-6M, as described above, the closure device may bean expandable or self expanding device that is configured to betransformable from a collapsed state to an expanded state whenunrestrained, in the case of a self expanding configuration, orunrestrained and actively expanded (for example, with an expansionballoon), in the case of an actively expandable configuration. Expansionof one embodiment is depicted in the transformation between FIG. 6K andFIG. 6L, wherein the collapsed closure device (86) is freed from theconstraints of one or more restraining members, such as a lumen orlumens of one or more sheaths, or one or more deployment attachmentmembers which may be looped around the collapsed configuration. FIG. 6Millustrates an orthogonal view of the expanded configuration of FIG. 6L.The expanded configuration of the depicted embodiment, illustrated inFIGS. 6L and 6M, comprises an expanded form of an expandable closuredevice (114) featuring a cylindrical pattern of nitinol frame elementsor structural members (30), coupled to a cover structure (32), similarto those described above in reference to FIGS. 1A-1J and 2A-2I. Asheetlike member may also be coupled to the frame elements to assistwith arteriotomy closure, as described above. As described above,preferably the cover (32) is sized to not only contain substantially theentire structure when in a collapsed configuration, but also to providea layer of arteriotomy closure and leak prevention when the device hasbeen expanded and the cover (32) has been oriented directly adjacent tothe location of the arteriotomy. Also as described above, the cover (32)may comprise a bioresorbable material, and in other embodiments,elements of the closure device (14, 24) structure may comprise apolymeric material which also may be bioresorbable. The cover (32) maybe coupled to the closure device (114) using a clip, wire, or suturewhich may be looped around one of the frame elements (30) and throughthe material comprising the cover (32). Geometric features may becreated in the closure device to assist with such coupling, and may beconfigured to allow for coupling of the cover and closure device withouta clip, wire, or suture.

Referring to FIGS. 6N-6O, three different views of a closure deviceframe or scaffold (116) configuration comprising two crowns coupledtogether, using a weld or adhesive junction, for example, areillustrated. A clip, wire, or suture around one of the crown junctionsmay be utilized to couple a cover to such device.

Referring to FIGS. 6Q and 6R, two different views of a closure deviceframe or scaffold embodiment (118) are shown wherein a small loopfeature (119) has been formed to assist with the coupling of suchscaffold and a cover. FIG. 6S depicts a similar embodiment (120) havinga larger loop feature (121). FIG. 6T depicts an embodiment (124) whereina loop feature (125) is formed with an end to end structural memberjunction that may comprise welds or adhesive junctions; FIG. 6U depictsa similar embodiment (126) with a larger loop feature (127). FIG. 6Vdepicts an embodiment (128) having several features of interest,including an end to end crimp tube junction (131), a small bend feature(130) which may be positioned to contain or assist with coupling anassociated cover member, and two pinch coil features (129) configured toretain a portion of a cover member with a pinch friction/load fit,somewhat akin to that provided to a piece of paper with a paper clip. Inother embodiments, pinch coil features (129) may be created at variouslocations about the closure device frame or scaffold structure, inaddition to the end apex locations as shown in the variation of FIG. 6V.

FIGS. 6W and 6X depict orthogonal and side views of another embodimentof a scaffold (248) comprising an omega type fitting (250) whichfacilitates attachment of one or more elongate fastening or tetheringmembers, such as sutures coupled to the scaffold or an associated covermember using one or more knots, in a manner wherein the knots need nottouch or mechanically interfere with each other, and wherein a sheetlikecover member may be closely interfaced with the scaffold (248) withoutthe knot or other fastening means creating a large gap between the coverand scaffold (such a gap can be disadvantageous in the endovascularenvironment, for example, for thrombus pooling, flow turbulence, andgeneral flow disruption reasons). In other words, each of the two sidesof the omega shape (250) can be used as a knot or fastening interface,and the gap defined by the center of the omega shape (250) maintains adistance between the two fastening interfaces which keeps them frommechanically rubbing against each other, and also provides a geometricpocket for the knots or fasteners to reside, thus allowing for a moredirect interfacing of an associated cover to the scaffold (248) withoutgaps required to accommodate an otherwise prominent fastener or knot.

Referring to FIG. 6Y, a scaffold embodiment (252) is depicted having twoend portions (254), each of which may comprise a non-resorbable metalliccoil, for example, and a central portion (256) coupling the two endportions (254), the central portion preferably comprising abioresorbable material such as polylactic acid or other resorbablepolymer or material, as discussed otherwise herein. Such an embodiment(252) may be utilized to seal a hole or other defect as describedherein, for example, using a cover member or the like, and afterdeployment and hemostasis at the defect, the central portion (256) isconfigured to bioabsorb away, leaving the end portions (254) remainingin situ where they may be encapsulated by endothelial cells, and theregion of the associated vessel immediately adjacent the previouslocation of the resorbable central portion (256) available for secondaryor revision access. In other words, the vessel portion adjacent theresorbable central portion (256) may be easily reaccessed because noimplantable hardware has been left behind from the previous interventionin this portion of the vessel.

In any of the embodiments of FIGS. 6N-6Y, a suitable frame or scaffoldmay be substantially cylindrical, with a diameter of between 6 and 14mm, more preferably between about 11 and 14 mm, and a length of betweenabout 12 and 20 mm, more preferably about 16 mm.

FIG. 6Z illustrates a side view of a delivery sheath (76), which maycomprise a generally cylindrical polymeric tube with sequentiallystepped down outer diameter shaping (to provide greater flexural modulusperformance and shaping distally) and an atraumatic tip (79) similar tothat shown in FIG. 6A (element 78 of FIG. 6A) comprising a partiallyhemispheric or capsular arcuate geometry with notches (80) to allow forpassage of closely fit objects (i.e., by bending forward/distally one ormore of the plurality of atraumatic tip flaps formed by the notches 80and capsular shape of the atraumatic tip 79) through a working lumenwhich preferably is formed and defined through the sheath (76). Asdescribed above, the introducer illustrated in FIG. 6A, for example, hassimilar atraumatic tip features, including a notched (80) partiallyhemispheric or capsular arcuate geometry (element 78 of FIG. 6A)configured to accommodate the passage of relatively closely fit objects(i.e., by bending forward/distally one or more of the plurality ofatraumatic tip flaps formed by the notches 80 and capsular shape of theatraumatic tip, element 78 of FIG. 6A).

FIG. 6Z-1 illustrates aspects of the proximal portions of a deliveryassembly which may be utilized with a distal deployment configurationsuch as that illustrated in FIG. 6A. Referring to FIG. 6Z-1, theoutermost layer of the distal aspects of the depicted configurationcomprises the delivery sheath (76), which terminates proximally with adelivery sheath hub (77) configured to be manipulated by an operator.Within the lumen defined by the delivery sheath is a delivery assemblycomprising an elongate deployment member (90) movably coupled to a footmember proximal portion (142). The elongate deployment member (90)terminates proximally with an elongate deployment member hub (91)configured to be manually manipulated by an operator. This hub (91)features a releasable termination screw (137) to fix one end or oneportion of a deployment tension member (82), the other portion or end ofwhich may be coupled to a pull tab (132) configured for tensionmanipulation by an operator to, for example, untie a highwayman's hitchknot configured to releasably contain a closure device in a collapsedconfiguration. The elongate deployment member hub (91) also features ascrew (144) adjustable compression spring (146). The proximal portion ofthe foot member (142) terminates proximally in a foot hub (140)configured to be manually manipulated by an operator. A set screw (138)may be utilized to fasten the hub (140) to the foot member (142). Theattachment tension member (84) is proximally routed through the proximalportion of the foot member (142) to a releasable fixation screw (136).The proximal portion of the foot member (142), which, as describedabove, may be reinforced by, or may comprise, a relatively stiffmaterial or construct, such as a metal hypotube. In operation, when anoperator wants to induce rotation and/or translation of a collapsedclosure device, as described, for example, in reference to FIGS. 6C-6E,he may longitudinally reposition the elongate deployment member hub(91), foot member hub (140), and attachment tension member (84)tensioning to create such rotation and/or translation of the distal footportion and collapsed closure device. A compression spring seat (148)coupled to the proximal portion of the foot member (142) applies loadsto the proximal portion of the foot member (142) as the foot member hub(140) is pushed toward the elongate deployment member hub (91). Ashoulder bolt (134) maintains the orientation of the foot memberrotationally to allow the operator to understand the direction offlexion of the foot member upon desired rotation and/or translation. Thecompression spring adjustment screw may be tightened to pre-bias thedistal foot portion to flex when released from constraining members,such as one or more sheaths which may temporarily surround andmechanically constrain the distal foot portion (i.e., thereby urging thedistal foot straight as opposed to flexed). Alternatively, the springmay be left relatively unloaded to allow for release from constrainingmembers without pre-biased flexion actuation, followed by controlledflexion actuation using the various hubs and attachment tension element.Aspects of embodiments of such operation are described in reference toFIGS. 7A-7F, and 8A-8B.

Referring to FIG. 7A, an assembly has been inserted through anarteriotomy (28) and advanced forward to place a collapsed closuredevice (86), such as those described above in reference to FIG. 1A-1J,2A-2I, 3A-3D, or 6L-6V, within a blood vessel (22) and surrounded by oneor more sheaths (76, 2). In some embodiments, the arteriotomy (28) mayhave a diameter as large as 18 French or greater. Referring to FIG. 7B,to begin deployment of the closure device (86), the introducer sheath(2) may be withdrawn proximally using an introducer manipulation hub(3), and/or the elongate deployment member (90) and foot member (142)may be advanced distally, to further expose the collapsed closure device(86). Referring to FIG. 7C, the delivery sheath (76) and collapsedclosure device (86) may be moved relative to each other to furtherexpose the collapsed closure device (86). Referring to FIG. 7D, theexposed collapsed closure device (86) may be controllably translatedand/or rotated to cause rotational reorientation to a toggled position.Referring to FIG. 7E, the closure device (86) is intentionallydimensioned to not be easily passable through the arteriotomy when inthe toggled position. In one embodiment, the closure device (86) mayhave a proximal portion, centerpoint, and distal portion along an axisparallel to a longitudinal axis of the closure device when collapsed orexpanded. Preferably the total length of the device along this axis isgreater than the largest dimension of the arteriotomy, and preferablythe distal portion and proximal portion are long enough to preventadditional rotation of the device relative to the longitudinal axis ofthe vessel (i.e., about an axis perpendicular to the longitudinal axisof the vessel). In one embodiment, the attachment tension member (84)may be tensioned to place the collapsed closure device (86) against thearteriotomy with the central point (154), adjacent to which theattachment tension member preferably is terminated upon the device,aligned with the center of the arteriotomy (28), and the proximal (156)and distal (158) portions of the device extending away from thearteriotomy (28). In other words, upon controlled repositioning and/orreorientation of the collapsed closure device to the toggled or rotatedposition, further withdrawal of the closure device out of thearteriotomy is prevented by virtue of the geometry of the arteriotomyand closure device, the device in the depicted embodiment (86 collapsed;88 expanded) spanning across the diameter of the previous arteriotomylocation with extra length to spare on either side of this previousarteriotomy location. Referring to FIG. 7F, the deployment tensionmember (not shown) has been tensioned to allow the closure device totake its expanded shape (88), preferably urging the associated coveragainst the inside of the arteriotomy, which shrinks to a closedconfiguration (27) when all of the hardware has been withdrawn with theexception of the attachment tension member (84), which is configured toremain attached to the expanded device (88), and is preferablyconfigured to subsequently biologically erode after being clipped mostproximally and allowed to stay inside of the body after transcutaneouswound closure.

Referring to FIG. 8A, a deployment process is outlined, whereinsubsequent to transcutaneous access and arteriotomy creation (160), anintroducer and associated hardware may be inserted through thearteriotomy and advanced through a portion of the artery (162). Adeployment assembly may be advanced (164) with the introducer, orsubsequently advanced, and may be exposed by moving the introducerlongitudinally relative to the deployment assembly. In one embodimentwherein the foot member is pre-biased to reorient by a proximal loadingconfiguration such as a compressed compression spring, when the distalportion of the foot member is cleared of mechanical confinement by adelivery sheath or introducer sheath, it flexes at the foot hinge orbend axis to reorient the collapsed closure device. In preparation forsuch reorientation, the introducer may be moved proximally relative tothe closure device (166). The deployment assembly may then be withdrawnto place the collapsed covered closure device immediately adjacent thetissue structure portions around the hole in the vessel (167). Thiswithdrawal may be facilitated by a bleedback indicator configured tosignal an operator when a predetermined amount of instrument insertionor retraction positioning has been achieved, as described below inreference to FIG. 11. In the depicted embodiment wherein the foot memberis pre-biased to flex when not constrained, the last anti-flexionconstraint, the delivery sheath, is withdrawn relative to the footmember, closure device, and elongate delivery member, and the closuredevice and distal portion of the foot become reoriented (168).Subsequently, the introducer, delivery sheath, and foot member/elongatedelivery member assembly may be withdrawn to allow the closure device tobe urged against the arteriotomy with tension in the attachment tensilemember (170). Subsequently, the deployment tension member may becontrollably tensioned to allow the closure device to expand in positionagainst the arteriotomy, preferably with a cover portion of the closuredevice positioned immediately adjacent the arteriotomy location (172).The deployment and access tools may be withdrawn, leaving behind onlythe expanded closure device and the attachment tension member, or“tether line” (176), which may subsequently be shortened prior totranscutaneous access closure (176).

Referring to FIG. 8B, another embodiment is depicted, differing fromthat of FIG. 8A in that the foot member is not pre-biased to flex uponrelease from constraining members such as an introducer sheath ordelivery sheath. In the embodiment of FIG. 8B, the collapsed closuredevice may be exposed to the bloodstream while the foot remains in anun-flexed configuration, and when the operator desires, may becontrollably rotated and/or translated into the rotated configurationwith a flexion inducing load applied deliberately (169).

Referring to FIGS. 9A-9E, another closure device deployment embodimentis depicted, wherein an elongate bending spring member is built into thefoot member to pre-bias the foot to flex when not constrained by aconstraining structure such as a delivery or introducer sheath.Referring to FIG. 9A, an assembly somewhat similar to that depicted inFIG. 6A is depicted, with the exception that the foot member (93)comprises an elongate bending spring member (178) extending through thedistal portion of the foot member, and also through some of the distalend of the proximal portion of the foot member. Preferably the elongatebending spring member (178) comprises a pre-bent metallic or polymericmember and is configured to assume a foot flexion position, as depictedin FIG. 9B, for example, when not otherwise constrained by a sheath orother contraining member to assume a straight position, as shown in FIG.9A. In one embodiment the elongate spring member comprises nitinolsuperalloy wire in a “V” shape as in FIG. 9D, and is coupled to proximaland distal foot member structures using interference fitting and adiscrete adhesive coupling at the distal tip of the “V” shape. In otherembodiments, the elongate spring member may comprise other biocompatiblemetals, such as stainless steel, cobalt chrome, titanium, nickel, gold,tantalum and/or alloys thereof, as well as biocompatible polymericmaterials such as polytetrafluoroethylene, expandedpolytetrafluoroethylene, polyethylene terepthalate, polyesther,polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid,fluorinated ethylene-propylene, silicone, polyethylene, polyurethane,and/or copolymers of any of the above. Further details of an elongatespring foot member are depicted in FIGS. 9C-9E. Referring to FIG. 9C,the elongate bending spring member (178) extends nearly the entirelength of the distal portion (184) of the foot member (93), and arelative small length of the distal end of the proximal portion (182) ofthe foot member (93). When allowed to rotate (i.e., without a sheath orother constraint holding it straight), as in FIG. 9E, the foot memberdistal portion (184) is configured to rotate to a preselected angle(186) in accordance with the pre-shaped configuration of the elongatespring member, about an axis of rotation, or bending or hinge point,(180) that divides the proximal portion (182) from the distal portion(184). In one embodiment: the preselected angle of rotational sweep isbetween about 90 degrees and about 180 degrees, and more preferablyabout 155 degrees; the distal foot portion (184) may be between about 7mm and about 30 mm, and more preferably about 20 mm; and the portion ofthe foot spring member (178) extending proximally from the flexion axis(180) may be between about 3 mm and about 15 mm, more preferably about 9mm. Referring to FIG. 9D, an orthogonal view illustrates the placementof a collapsed closure device (86) relative to the distal portion (184)of the foot member, such distal portion (184) being in an unfoldedconfiguration in FIG. 9D, to accommodate interfacing and coupling with acollapsed closure device (86). Four holes in the distal portion (184) ofthe foot are configured to assist with releasable fastening of adeployment tension member (element 82 in FIG. 9A) using a releasableknot, such as a highwayman's hitch. The distal portion (184) of the footmember may be created by crushing flat a substantially cylindrical pieceof tubing comprising the proximal portion (182) of the foot member, andcreating an “H”-shaped slice in such flattened portion to create thewings (232, 234) configuration depicted in FIG. 9D. Each of the wings(232, 234) is configured to be wrapped around the exterior of acollapsed closure device (86) to form a stable saddle-like interface.Two additional holes (204, 206) are formed through the foot member (93),one (204) to accommodate a deployment tension member (element 82 in FIG.9A), and the other (206) to accommodate an attachment tension member(element 84 in FIG. 9A). Some sample dimensions for one particularembodiment include a collapsed closure device length dimension (188) ofabout 0.5″, a bending axis to proximal end of collapsed closure devicedimension (190) of about 0.125″, a distal tip of foot member to distalend of collapsed closure device dimension (192) of about 0.25″, a distalend of collapsed closure device to distal wing edge dimension (194) ofabout 1/16″, a distal end of foot member to distal wing edge dimension(196) of about 5/16″, a deployment member hole to proximal wing edgedimension (198) of about 1/16″, and a wing length dimension (200) ofabout 0.25″.

Referring to FIG. 10, a process for utilizing an arteriotomy closuresystem such as that described in reference to FIGS. 9A-9E is depicted,with steps similar to those described in reference to FIG. 8A, with theexception of inserting a deployment assembly wherein the associated footmember comprises a pre-formed nitinol (“NiTi” or nickel titanium alloy)member biased to flex the distal foot portion at the rotational (orhinge or bending) axis when freed of confinement by a confiningstructure such as a delivery or introducer sheath (208).

Referring to FIG. 11, a particular embodiment of a deployment sheath(76) is depicted, wherein a blood, or “bleedback”, channel (210) isformed within the exterior surface of the sheath (76) to allowpressurized blood, when present at the distal tip (79) of the sheath(76), to flow from the distal end of the sheath, proximally through thechannel (with an introducer sheath in place over the deployment sheath,the channel would be confined at the outer surface by the inside surfaceof the introducer lumen, but would remain free to flow through thechannel proximally), to a lumen inlet (212), the associated lumen (214)being fluidly connected with a simple indicator fitting (216) configuredto effectively ooze or squirt blood when appropriate blood pressure ispresent at the distal end of the channel (210). Such a configuration maybe utilized in the relatively high-pressure (relative to venous)arterial system where arteriotomies are created, to provide anindication to an operator that the distal portion of the subject sheath(79) is at an insertion or retraction position wherein it is exposed toarterial flow. In one embodiment, such an indication may be utilized toposition the distal portion of such sheath (79) just at the transitionout of the arteriotomy and into non-pressurized space, when conducting aclosure device deployment, as described above.

Referring to FIGS. 12A-12D, various aspects of a manual interface orcontrol handle assembly for operating a closure device deploymentsystem, such as those described in reference to FIGS. 6A-6X and 9A-9E,are illustrated. Referring to FIG. 12A, in one embodiment the controlhandle assembly (220) comprising a manipulable handle housing (218) andtwo manually movable elements (222, 224) configured to assist withvarious aspects of the deployment, is coupled to an elongate deploymentmember (90). Referring to the partial cutaway view of FIG. 12B, a footmember (93) extends distally through the elongate deployment member (90)and proximally is coupled to the first manually movable element (222),which is slidably coupled to the handle housing (218) to facilitateconvenient thumb or finger insertion/retraction of the foot member (93)relative to the elongate deployment member (90). Extending proximallyfrom the foot member (93), an attachment tension member (84) is coupledto a second manually movable element (224) by way of a spring-loadedmechanical fitting (226) configured to provide the operator with atactile bump in tensile pull (using, for example, a small enlargement inthe tension member that passes a fitting within the spring-loadedmechanical fitting) when he is about to release the attachment tensionmember from the housing, such that it may be left in situ. In operation,when the second movable element (224) is pulled proximally by a smallamount (228) as in FIG. 12C, the movable element (224) detaches from thehousing. Additional proximal pulling (230), as shown in FIG. 12D, takesthe attachment tension member (84) past the detent, bump, or pull limittactile feedback mechanism, to provide the operator with anunderstanding that pulling past such point permanently releases theattachment tension member (84) from the housing (84) and the controlhandle assembly (220) in general.

Referring to FIG. 13A, an assembly (290) similar to that of FIG. 9A isdepicted, with the exception that a catch member (258) is depictedextending proximally away from the proximal end of the collapsed closuredevice (86). In the depicted embodiment, the catch member (258) iscoupled to an elongate member (260) which has a distal extension (266)that extends distally past the junction of the catch member (258) andthe elongate member (260). The assembly (288) of FIG. 13B has similarelements as shown in FIG. 13A, with the exception that the introducersheath (2) and delivery sheath (76) have been removed. Referring to FIG.13C, when the distal aspect of the foot member (93) is moved, asdescribed above in reference to FIG. 9B, for example, the catch member(258) also becomes reoriented, to a configuration wherein the proximalaspect of the catch member sticks out, away from the remaining portionsof the delivery assembly, to facilitate “catching” tissue structureswhich may be nearby, such as the tissue which may surround a hole ordefect. This “catching” affect desirably prevents the associated closuredevice (86) from exiting such defect or hole, as described furtherbelow. Further, this catching affect assists with docking of thecollapsed state of the implantable closure device adjacent thearteriotomy, and may also be useful in mechanically supporting theportions of the vessel that lie immediately adjacent the catch member(i.e., in one configuration, the catch member may be utilized to preventcollapse of the immediately adjacent vessel portions). Referring to FIG.13D, in one embodiment, the catch member (258) may be controllablyretracted forward (268) with advancement (262) of the elongate push/pullmember (260) through manual manipulation. Such advancement of theelongate member (260) causes advancement (264) of the distal extension(266), which guides the catch member (258) forward and into alignmentwith the distal extension (266), into a retracted position as shown inFIG. 13D. Such retracted position may be utilized to retract a deliveryassembly back through the hole or defect after deployment of a closuredevice. Referring to FIGS. 14A and 14B, a similar catch memberfunctionality may be achieved in one embodiment by advancing (274)and/or retracting a guidewire (270) through a lumen created in the footmember (93) to cause a guidewire distal tip portion (272) to be advancedoutward (276) relative to the collapsed closure device (86) in a“catching” configuration, or retracted back to facilitate removal of theassembly through the hole or defect.

Referring to the three different orthogonal views of FIGS. 15A-15C, acatch member extension (261) may comprise a portion of the closuredevice scaffold (278), as opposed to a separate movable member asdescribed above in reference to FIGS. 13A-14B. Such a catch memberextension (261) is not configured to be retractable, but need not be, asit is decouplable from the delivery tools, and such tools may thereforebe retracted away through the hole or defect without concerns forreconfiguring the catch member for such retraction (i.e., because inthis embodiment, the catch member need not be withdrawn back through thehole or defect after closure device deployment). Also shown in FIGS.15A-15C are small omega formations (282) which may be utilized forfastening tethers, a cover, and the like, as described above inreference to FIGS. 6W and 6X. Further, a wire coupling is shown,comprising a sleeve (286) that is fitted over to abutted ends of thewire comprising the depicted scaffold (278) and welded (284) in place toform a robust junction by melting the sleeve over the wire ends. In oneembodiment, the inner diameter of the sleeve may be about ½ of athousandth of an inch larger than the outer diameter of the wire, for atight fit, before the sleeve is melted (notwithstanding the fact that inone embodiment, both the wires and sleeve comprise NiTi material,preferably the wires remain unmelted and as intact as possible), forminga low-profile filleted joint which may be electropolished for smoothingbefore attachment of a cover member, tether, or other part. In otherembodiments, such a junction may be created using adhesive bonding,crimping, press fit techniques, and/or thermal expansion/contractiontechniques.

Referring to FIGS. 16A-16K, various aspects of a deployment areconfigured utilizing embodiments similar to those described in referenceto FIGS. 13A-13D above. Referring to FIG. 16A, an assembly (290) similarto that of FIG. 13A is depicted being inserted through an arteriotomy(28) formed in a vessel (22). Referring to FIG. 16B, the delivery sheath(76) and collapsed closure device (86) may be advanced relative to theintroducer sheath (2) to expose the delivery sheath (76) and collapsedclosure device (86) to the bloodstream of the vessel (22). The deliverysheath (76) may comprise a channel or lumen for providing bleedbackfeedback to the operator, as described in reference to FIG. 11, suchthat the operator may insert and/or withdraw the delivery sheath (76)and collapsed closure device (86) until a desirable predetermined levelof insertion is achieved, based upon the feedback from the bleedbackconfiguration. Referring to FIG. 16C, with the delivery sheath (76) andcollapsed closure device (86) optimally inserted relative to thearteriotomy (28), the delivery sheath (76) may be controllably withdrawnwhile the longitudinal position of the collapsed closure device (86) ismaintained, and as shown in FIG. 16D, the foot member may be utilized toinduce repositioning (in the depicted embodiment, rotationalrepositioning or reorienting) of both the collapsed closure device (86)and the catch member (258). Referring to FIGS. 16E and 16F, theintroducer sheath (2) and delivery sheath (78) may be further withdrawn,and the collapsed closure device (86) and catch member (258) may bewithdrawn or urged toward the tissue (292) surrounding the arteriotomy.As shown in FIG. 16F, the catch member interfaces with the nearby tissue(292) and geometrically prevents the closure device (86) from beingwithdrawn out of the arteriotomy (28). With the collapsed closure device(86) appropriately positioned and oriented prior to expansion of theclosure device to an expanded configuration, the closure device may beexpanded to the expanded configuration (88), as shown in thetransformation from FIG. 16G to FIG. 16H. Referring to FIG. 16I, withthe closure device (88) deployed into the expanded configuration, theelongate deployment member (90), foot member (93), and catch member(258) and associated elongate member (260) may be withdrawn proximally,preferably after the elongate member (260) has been advanced relative tothe foot member (93) to place the catch member into a withdrawnconfiguration, as described above. As shown in FIG. 16J, the introducersheath (2) and delivery sheath (76) may also be withdrawn, leavingbehind the attachment tensile member (83) which is coupled to theclosure device (88). Referring to FIG. 16K, in one embodiment, aresorbable compressive member (294), such as a sheet or cylindrical plugmember (294) of collagen or other bioresorbable material slidablycoupled to the attachment tensile member (83), may be advanced towardthe arteriotomy to place the arteriotomy wound in compression betweenthe member (294) and the deployed closure device (88). The surroundingtissue would serve to maintain the position of the member (294) relativeto the arteriotomy, but in one embodiment, one or more sutures may beutilized to fasten the member (294) in position relative to thearteriotomy (28). In another embodiment, a flowable material, such ashydogel or other pro-thrombal agent selected to promote healing and/orclotting, may be dispensed adjacent the arteriotomy.

Referring to FIG. 17, a process embodiment is illustrated featuringconfigurations such as those described above in reference to FIGS.16A-16K. Referring to FIG. 17, with several steps in common with theprocess embodiments described in reference to FIGS. 8A, 8B, and 10,after transcutaneous access and arteriotomy are created (160) andintroducer advancement (162), a deployment assembly comprising acollapsed closure device movably coupled to a proximal catch member andother tools may be inserted through the introducer (208), positionedrelative to the end of the introducer (166), and adjusted longitudinallyto a position near the arteriotomy (for example, using bleedbackdetection to confirm longitudinal positioning relative to apredetermined position associated with bleedback, as described above inreference to FIG. 11; 167). The foot may be controllably flexed toreorient and/or reposition the collapsed closure device and catch member(296), after which the collapsed closure device and catch member may beurged into a position adjacent and/or against the arteriotomy, with thecatch member in position to prevent withdrawal or escape of the closuredevice through the arteriotomy (298). Subsequently the closure devicemay be expanded to the expanded configuration (172), the catch membermay be retracted to a withdrawal configuration (300), other deploymenttools may be retracted/withdrawn (174), and the free length of tetherremaining may be shorted before transcutaneous access is closed.

Referring to FIGS. 18A-18C, a fully bioresorbable closure deviceconfiguration is depicted. Referring to FIG. 18A, in a collapsedconfiguration (322), a “furling”/“unfurling” closure device (320) in the“furled” or collapsed state has a relatively small outer diameter.Referring to FIG. 18B, with tension on the one or more tensioningelements (328, 330), which may be coupled to the depicted couplingpoints (332, 334), or in another embodiment featuring four tensioningelements (not shown), to the other depicted coupling points (344—fourcorners of the substantially rectangular sheetlike closure device), andconcomitant pushing of a cinching member (326) toward the closure device(i.e., to create a compressive load 338 between the cinching member 326and closure device 324), the closure device assumes an expandedconfiguration (324) wherein a substantially cylindrical shape isassumed, at least in part. In the depicted embodiment, the arc lengthoccupied by the expanded closure device (324) represents approximately ⅔of the circumference of a full cylindrical shape. In another embodiment,the expanded closure device (324) represents approximately ½ of thecircumference of a full cylindrical shape. The cinching member (326) maycomprise a housing through which the one or more tensioning elements arepassed, and may comprise a locking feature, such as a simple reed lock(i.e., as in a “zip tie” locking mechanism) to allow only tighteningmovement. The middle portion (342) adjacent the tensioning memberportions coupling to the closure device (324) may be reinforced toprevent bucking under the applied loads—to facilitate controllableexpansion with applied tensioning (340) and compression (338) of thecinching member (326). Referring to FIG. 18C, a side view of a deployedconfiguration such as that illustrated in FIG. 18B is depicted, showingthe expanded closure device configuration (324) occluding thearteriotomy (28).

In another embodiment similar to that illustrated in FIGS. 18A-18C, oneor more portions of such embodiment may be nonresorbable. For example,in one embodiment, a sheetlike portion of the unfurling prosthesis (320)may be bioresorbable, while one or more structural members comprisingmaterials such as one or more nonresorbable metals or polymers may becoupled to the sheetlike portion to assist with the unfurling or otherdeployment steps or configurations.

Referring to FIG. 19, a process for utilizing a configuration such asthat described in reference to FIGS. 18A-18C is illustrated. Referringto FIG. 19, after transcutaneous access and arteriotomy creation (160)and introducer advancement (162), a deployment assembly comprising arotationally-compressed, or “furled”, closure device may be advancedinto position through the introducer (312). The distal portion of thedeployment assembly may be positioned relative to the introducer (166),and bleedback may be utilized to assist with positioning relative to thearteriotomy (167) before retracting the delivery sheath and allowing therotationally-compressed closure device to have direct access to theinterior of the artery (314), adjust in position relative to thearteriotomy (316), expand or “unfurl” to close the arteriotomy(318)—i.e., by applying tension to associated tension elements, followedby removal of associated tools (174) and final tether shortening andwound closure (176).

Referring to FIGS. 20A-20K, an embodiment similar to that described inreference to FIGS. 16A-16K is illustrated, the embodiment of FIGS.20A-20 k featuring use of a guiding member such as a guidewire tofacilitate efficient return to the arteriotomy location in anover-the-wire configuration after closure, until such guiding member orwire is removed. Referring to FIGS. 20A and 20B, an assembly is insertedand positioned as in FIGS. 16A and 16B. Referring to FIG. 20C, a guidingmember (302), such as a guidewire, is inserted through a lumen definedin the foot member or elongate deployment member, through the collapsedclosure device (86), and out distally into the vascular lumen. Inanother embodiment, a distal portion guiding member (302) may bepreadvanced to a location within the collapsed closure device (86)before any instrumentation is inserted through the arteriotomy (28) asin FIGS. 20A and 20B. With the guiding member in place, the deploymentof the closure device (86, 88) is continued, as shown in FIGS. 20D-20J,which parallel the deployment steps of FIGS. 16D-16J (with the exceptionthat a plug member 294 is not shown in the embodiment of FIG. 20J, and aguiding member 302 is present in each step). Referring to FIG. 20J, withthe tether member clipped and the closure device expanded (88), theguiding member (302) may remain in place until a time that the surgeondecides it may be removed (as in FIG. 20K), which may occur well afterhemostasis of the arteriotomy. Should the operating team need fast andefficient access to the location of the arteriotomy and the associatedvessel lumen while the guiding member remains in place, an over-the-wireprocedure may be utilized to take further instrumentation directly tothe site.

Referring to FIG. 21, a process for utilizing configurations such asthose featured in FIGS. 20A-20K is illustrated. As shown in FIG. 21,after transcutaneous access and arteriotomy are created (160), anintroducer advanced (162), and in this embodiment, a deployment assemblyfeaturing a catch member inserted (208), and repositioned relative tothe introducer (166), a guiding member such as a guidewire may beintroduced (304), after which the deployment assembly may be withdrawnwith feedback from a bleedback configuration, as described above inreference to FIG. 11 (167). The foot member may be utilized toreposition and/or reorient the collapsed closure device and catch member(296), followed by urging the collapsed closure device and catch memberagainst the arteriotomy location (298), expansion of the closure device(172), controlled retraction of the catch member (300), retraction ofassociated tools—with exception of the guiding member, which may be leftin place (306), and shortening of the free length of the tether memberwhile leaving the arteriotomy provisionally closed over the guidingmember. After the surgical team decides that a deployed guiding memberis no longer warranted, the guiding member may be removed (310),preferably by gently tensioning/pulling it out through the arteriotomy.

Referring to FIG. 22A, an embodiment similar to that depicted in FIG.20G is depicted without the associated anatomy. FIG. 22B depicts aclose-up view to illustrate that in one embodiment, the guiding member(302) may be passed through a lumen defined in part by a foot memberportion (95), and in part by a conduit branch (99) configured to extendaway from the foot member into the interior of the closure device (86),to direct the guiding member out into the vascular lumen without furtherentanglement. Referring to FIG. 22C, in another embodiment, the distalaspect of a foot member may be directed down into the closure device(86) to function both as a foot member for deployment purposes, and alsoas a guiding member conduit, without the need for a conduit branch(99—in FIG. 22B). In either variation, a small entry port (101) iscreated where the guiding member (302) exits the closure device (86),and this port (101) may be closed to facilitate hemostasis after removalof the guiding member by application of direct pressure, a small flapdoor that is biased to close, one or more sutures that may becontrollably tensioned to close the port, or a plug member usedsimilarly as described in reference to FIG. 16J.

Referring to FIG. 23A, a simple illustration of a collapsed closuredevice (86) and associated catch member (258) is depicted. Referring toFIGS. 23B and 23C, in another embodiment, a distal catch member (259)comprising similar materials and being similarly controllablywithdraw-able and/or repositionable, may be associated with the closuredevice (86) to prevent exit of the distal portion of the closure deviceback through the arteriotomy. The embodiment of FIG. 23C shows thedistal catch member in a somewhat withdrawn configuration which mayfacilitate delivery and advancement through the arteriotomy. Theembodiment of FIG. 23C shows the distal catch member in a fully extendedposition wherein it is configured to prevent withdrawal of the closuredevice (86) through an associated arteriotomy. The change from withdrawnto extended positions may be controllably executed by an operatorpulling or pushing a push or pull member, such as a pushrod or tensionelement such as a wire or suture.

Referring to FIGS. 24 and 25, embodiments are illustrated wherein aguidewire is inserted before introduction of a deployment assembly, withother steps similar to those of other aforementioned embodiments, suchas that of FIG. 21. Referring to FIG. 24, after creation oftranscutaneous access and an arteriotomy, a guidewire (“GW”) may beintroduced to reach the interior of the artery (346). Subsequently, anintroducer may be advanced in an over-the-wire configuration (348),followed by a deployment assembly through the introducer andover-the-wire. Subsequent steps are similar to those described inreference to the illustrative embodiment of FIG. 21. Referring to FIG.25, an embodiment similar to that of FIG. 24 is depicted, with theexception that the guidewire (“GW”) may be utilized to assist withpositioning of the deployment assembly—without the use of an introducer.As shown in FIG. 25, after creation of transcutaneous access and anarteriotomy (160), the guidewire may be introduced (346), followed bythe deployment assembly in an over-the-wire configuration, without anintroducer (352). Subsequently the deployment assembly position may beadjusted, without the presence of an introducer (354), and the remainingsteps may be similar to those described in reference to the illustrativeembodiment of FIG. 21.

Various exemplary embodiments of the invention are described herein.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject interventionsmay be provided in packaged combination for use in executing suchinterventions. These supply “kits” further may include instructions foruse and be packaged in sterile trays or containers as commonly employedfor such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally know or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

The breadth of the present invention is not to be limited to theexamples provided and/or the subject specification, but rather only bythe scope of claim language associated with this disclosure.

1. A method for closing a hole in a vessel, comprising: a. insertingthrough the hole an implantable closure device having proximal anddistal ends and being expandable from a collapsed state to an expandedstate, the expanded state providing a geometry sufficient tosubstantially occlude the hole; b. inserting a distal portion of anelongate guiding member through the hole and into a vascular lumenformed by the vessel; and c. controllably expanding the implantableclosure device to the expanded state to occlude the hole, while leavingthe distal portion of the elongate guiding member extending into thevascular lumen.
 2. The method of claim 1, further comprising insertingan introducer sheath through the hole, the introducer sheath defining anintroducer lumen sized to accommodate insertion of the collapsed stateof the closure device.
 3. The method of claim 1, wherein insertingcomprises advancing the implantable closure device relative to the holewith a deployment member having a proximal portion configured for manualmanipulation and a distal portion configured to be removably coupled tothe implantable closure device.
 4. The method of claim 3, furthercomprising controllably moving the collapsed closure device relative tothe deployment member to place the closure device into a geometricconfiguration relative to the vascular lumen that is selected to preventwithdrawal of the closure device back out of the hole.
 5. The method ofclaim 4, wherein controllably moving comprises rotating the collapsedclosure device relative to the deployment member to place the closuredevice into a rotated orientation selected to prevent withdrawal of theclosure device back out of the hole when the deployment member iswithdrawn.
 6. The method of claim 4, wherein controllably movingcomprises translating the collapsed closure device relative to thedeployment member to place the closure device into compression against aportion of the deployment member.
 7. The method of claim 6, whereintranslating causes the collapsed closure device to controllably rotateto a rotated orientation selected to prevent withdrawal of the closuredevice back out of the hole.
 8. The method of claim 2, furthercomprising advancing an assembly of a delivery sheath and collapsedimplantable closure device, at least a portion of which is removablypositioned within the introducer lumen, to a deployment position withinthe vascular lumen wherein reconfiguration of the implantable devicefrom the collapsed state to the expanded state is desired, andmaintaining the position of the collapsed implantable device whileretracting the delivery sheath to expose the collapsed implantabledevice to the vascular lumen.
 9. The method of claim 8, furthercomprising selecting the deployment position based at least in part uponan indication from a bleedback indicator channel.
 10. The method ofclaim 1, further comprising urging the expanded implantable closuredevice toward the hole, wherein the expanded state is configured tocontact at least 90 degrees of an inner surface of the vessel adjacentthe hole relative to a longitudinal axis of the vascular lumen, and torestrict fluids from exiting the vascular lumen through the hole. 11.The method of claim 1, wherein the closure device is a self expandingstructure configured to expand itself from the collapsed state to theexpanded state when not restrained in the collapsed state.
 12. Themethod of claim 11, wherein controllably expanding comprises moving aportion of a deployment tensile element relative to the self expandingstructure to allow the self expanding structure to expand itself to theexpanded state.
 13. The method of claim 1, wherein the closure deviceexpanded state forms a substantially cylindrical shape defining a lumentherethrough.
 14. The method of claim 1, wherein the elongate guidingmember comprises a guidewire.
 15. The method of claim 3, whereininserting the elongate guiding member through the hole comprisesadvancing the elongate guiding member through a lumen defined throughthe deployment member.
 16. The method of claim 1, wherein the elongateguiding member is removably coupled to the implantable closure device.17. The method of claim 3, further comprising decoupling the deploymentmember from the implantable closure device while leaving the distalportion of the elongate guiding member extending into the vascularlumen.
 18. The method of claim 17, further comprising engaging theelongate guiding member to re-enter the vascular lumen in anover-the-wire configuration.
 19. The method of claim 17, furthercomprising removing the elongate guiding member from the vascular lumen.20. The method of claim 1, wherein at least the distal portion of theelongate guiding member comprises a radioopaque material selected to bevisible with fluoroscopic imaging.
 21. The method of claim 1, whereinthe implantable closure device is inserted through the hole before theelongate guiding member.
 22. The method of claim 1, wherein the elongateguiding member is inserted through the hole before the implantableclosure device.
 23. The method of claim 22, wherein the implantableclosure device is inserted through the hole and over the elongateguiding member in an over-the-wire configuration.